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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device system, x-ray, mobile
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPT. OF THE ARMY
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 8
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
Minxray Inc
  SUBSTANTIALLY EQUIVALENT 10
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 5
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Device Issue 11
Malfunction 10
Electrical shorting 4
Unintended movement 3
Computer software issue 3
Mechanical issue 3
Self-activation or keying 2
Fire 2
Break 2
Data Issue 2
Component falling 2
Device operates differently than expected 2
Use of Device Issue 2
Device displays error message 2
Radiation Overexposure 2
Spark 1
Failure to fire 1
Battery issue 1
Detachment of device or device component 1
Unknown (for use when the device problem is not known) 1
Low battery 1
Electronic property issue 1
Environmental control or utility issue 1
Human-Device Interface Issue 1
Material integrity issue 1
No Known Device Problem 1
Calibration error 1
Failure to charge 1
Collapse 1
Image orientation incorrect 1
Disassembly 1
Electrical issue 1
Slippage of device or device component 1
Smoking 1
Sticking 1
Device stops intermittently 1
Device inoperable 1
Poor quality image 1
Device emits odor 1
Unintended collision 1
Unintended system motion 1
Device Difficult to Setup or Prepare 1
Total Device Problems 79

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 3 0 1 3 2 12 10 9 6 3
Class III 0 0 0 0 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Corp. II Jul-21-2014
2 AGFA Corp. II Jun-06-2013
3 AGFA Healthcare Corp. II Jun-10-2015
4 AGFA Healthcare Corp. III Aug-10-2014
5 Carestream Health Inc II Dec-16-2014
6 Carestream Health Inc. II Jan-03-2014
7 Carestream Health Inc. II Nov-07-2013
8 Carestream Health Inc. II Nov-01-2013
9 Carestream Health, Inc. II Jan-21-2014
10 Carestream Health, Inc. II Oct-31-2013
11 Carestream Health, Inc. II Oct-31-2013
12 GE Healthcare II Apr-27-2015
13 GE Healthcare, LLC II Jan-11-2014
14 GE Healthcare, LLC II Aug-09-2013
15 GE Healthcare, LLC II Apr-10-2013
16 GE Healthcare, LLC II Nov-29-2012
17 GE Healthcare, LLC II Sep-13-2012
18 GE Healthcare, LLC II Jul-19-2012
19 GE Healthcare, LLC II Apr-24-2012
20 GE Medical Systems LLC II May-22-2007
21 GE Medical Systems, LLC II Feb-08-2016
22 GE OEC Medical Systems, Inc II Aug-01-2012
23 Medtronic Navigation, Inc II Feb-04-2009
24 Medtronic Navigation, Inc. II Jun-21-2012
25 Medtronic Navigation, Inc. II Nov-23-2010
26 Philips Healthcare Inc. II Aug-21-2013
27 Philips Healthcare Inc. II Jun-13-2012
28 Philips Healthcare Inc. II May-30-2012
29 Philips Medical Systems North America Co. Phillips II Mar-08-2011
30 Philips Medical Systems North America Co. Phillips II Sep-25-2007
31 Philips Medical Systems, Inc. II Dec-16-2014
32 Sedecal S.A. II Mar-08-2016
33 Sedecal S.A. II Aug-14-2015
34 Sedecal S.A. II Feb-02-2015
35 Sedecal USA, Inc. II Jun-03-2016
36 Shimadzu Medical Systems II Dec-18-2015
37 Shimadzu Medical Systems II Mar-07-2014
38 Shimadzu Medical Systems II Jun-03-2013
39 Shimadzu Medical Systems II Nov-08-2012
40 Siemens Medical Solutions USA, Inc II Jul-02-2014
41 Siemens Medical Solutions USA, Inc II Aug-05-2013
42 Siemens Medical Solutions USA, Inc II Dec-06-2012
43 Siemens Medical Solutions USA, Inc II Sep-11-2012
44 Siemens Medical Solutions USA, Inc II Sep-06-2012
45 Siemens Medical Solutions USA, Inc II Aug-11-2011
46 Siemens Medical Solutions USA, Inc II Dec-17-2010
47 Siemens Medical Solutions USA, Inc II Nov-01-2010
48 Siemens Medical Solutions USA, Inc II Apr-19-2007
49 Trans American Medical, Inc. II Jan-03-2014
50 Virtual Imaging, Inc. II Feb-09-2015

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